Custom three dimensional forming of surgical guides

ABSTRACT

A kit including a medical guide template, and a sterilizable receptacle accommodating the guide template, the kit being configured to allow deformation of the template into an operational medical guide.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. application Ser. No.15/525,151 filed May 8, 2017, which is a 35 U.S.C. § 371 national phaseapplication of PCT/IL2015/051079, filed Nov. 9, 2015, which claimspriority to U.S. 62/077,247 filed on Nov. 9, 2014. All applications areincorporated herein by reference as if fully set forth.

FIELD OF THE INVENTION

The invention relates to medical devices that include medical guidesfrom deformable materials, guides made by 3-D printing and guides madewithin sterile receptacles, and systems that manufacture these guides.

BACKGROUND OF INVENTION

Some surgical interventions are performed inside the body with the aidof a surgical guide. In spinal surgeries a correct trajectory for amedical device is usually crucial, whereas in surgeries of small regionsin the body an accurate targeting distance from the device to the targetis particularly important. In addition, stereotaxic systems may be usedin the intervention. Stereotaxy is a minimally invasive form of surgicalintervention which makes use of a three-dimensional coordinate system tolocate small targets or trajectories inside the body and to perform onthem some medical action. In theory, any part inside the body can besubjected to stereotactic surgery, such as cranial, neurological,spinal, dental, orthopaedic, and ENT (ear, nose and throat) systems.

Plain X-ray images, computed tomography, magnetic resonance imaging andother imaging methods can be used to guide the procedure. Typically, theimages of anatomical structure (for example, a human brain), arecollected and related to a coordinate system. A guide calibrated to thesame coordinate system may be used to direct a medical device to thetarget or along a certain trajectory. In most stereotactic brainsurgeries locators/markers/fiducial-points serve as relative locationsfor the guide engagement.

Adjusting the guide to provide the correct distance of a medical deviceto a target and/or the correct trajectory within the body can be complexand time consuming. Moreover, in some procedures multiple targets ortrajectories must be determined. For example, in spinal stereotacticsurgery, multiple trajectories on different spinal segments are used.One option to align the guide includes providing an adjustableinstrument guide. However, the adjustments of the adjustable guiderequire careful manual manipulations which significantly prolong theoperation, and might be difficult to perform in some procedures, such asin dental operations wherein the maneuverability is severely limited andthe guide parts are miniature. Another option includes providing acustomized guide that is fabricated for a particular patient, such thattargeting is unnecessary or greatly simplified.

EP 1094760 describes a method for forming a surgical guide (guide) forattaching to a body and providing a reference structure for preciselylocating a target within the body, the method including: processing athree-dimensional scanned image of the body, the scanned image includingthe target within the body and a mounting location of the body;determining a structure of the surgical guide such that when attached atthe mounting location of the body the guide provides a referencestructure in a determined location and orientation with respect to thetarget within the body.

One of the method options described in EP 1094760 involves selecting amodel of a standard guide and deforming the model to match the model tothe target and the mounting location. As further described in EP1094760, the structure of the guide can be determined in terms of asolid model of the guide which defines the volume enclosed by thesurface of the guide. The solid model is computed so that the resultingguide can be precisely attached to the body. The method can then alsoinclude fabricating the guide according to the solid model. Clearly,therefore, the “solid” model that is described in EP 1094760 is actuallya software representation of the guide.

Some medical procedures, such as deep brain surgery, involvetrial-and-error location of the target, which in some operations entailsremanufacturing or reconfiguration of the guide or the stereotacticguiding system, as well as resterilization.

In such cases, the method described in EP 1094760 does not preventrescheduling of the operation to a different day.

One object of the invention is to allow reforming a guide quickly enoughto allow the operation to continue; preferably a new guide would beformed within mere minutes or even seconds.

Medical robotic systems such as ROSA allow frameless stereotacticprocedures and thus docs not require fabrication of a guide. Instead,stereotactic reference points for the robot are determined from imagesand quickly adjusted if the target is discovered to be at anotherlocation. However, the robotic system has a number of disadvantages aswell: engagement of the robot with the patient is uncomfortable andhighly complex; the robot needs to be sterilized before each operation;the robotic system is expensive and occupies a large space in theoperating room; the accurate positioning of the system requiresconsiderable skill; the system is dedicated to one patient during oneoperation session. For operations such as installing screws in the spinethe robot needs to be repositioned many times, which prolongs theoperation and the time the robot is needed per patient.

The Da Vinci Surgical System is another robotic surgical system, made byIntuitive Surgical. The system is controlled by a surgeon from aconsole. Although the system can multitask with a number of arms,nevertheless readjustment of positions in real-time throughout theoperation requires dedication of the system to the operation and thesystem has other disadvantages similar to ROSA. The da Vinci system hasparticularly been criticized for its cost and for a number of issueswith its surgical performance. The present invention intends to addressthese problems.

SUMMARY OF THE INVENTION

It is therefore provided in accordance with a preferred embodiment ofthe invention A kit comprising:

-   -   a medical guide template, and    -   a sterilizable receptacle accommodating the guide template,    -   wherein the kit is configured to allow deformation of the        template into an operational medical guide.

In accordance with another embodiment, said medical guide template is acurable template bulk.

In accordance with another embodiment, said curable template is curedusing U V light.

In accordance with another embodiment, said medical guide template ismade of a plurality of components that are capable of being movedrelative to each other with multiple degrees of freedom and whereincurable adhesive material is placed in joints between the components.

It is also provided in accordance with another preferred embodiment, amedical guide template configured to allow deformation thereof into anoperational medical guide and prevention of collapse thereof during andafter the deformation.

In accordance with another embodiment, the template comprising a groupcomprising of:

-   -   at least one deformable material;    -   a plurality of components that are capable of being moved        relative to each other, and    -   combinations thereof.

In accordance with another embodiment, the template comprising curablematerial.

In accordance with another embodiment, the deformable material iscurable.

In accordance with another embodiment, the curable material is incontact with at least two of the plurality of components.

In accordance with another embodiment, an operational guide is providedthat comprises:

-   -   at least one base element capable of engaging body anchoring        points;    -   at least one targeting element, each targeting element being        capable of engaging at least one medical device, and    -   connective structural elements connecting the at least one base        element with the at least one targeting element;        wherein the guide allows the medical devices to access at least        one target when the at least one base element is engaged with        the body anchoring points and the at least one medical device is        engaged with the at least one targeting element, and        wherein the connective structural elements are deformed.

In accordance with another embodiment, the deformation is based uponfiducial-points for the operational guide engagement, and wherein theguide is attachable to anchoring points that are attached to the body,the anchoring points being in a measured relation to thefiducial-points.

A system is also provided comprising:

-   -   markers;    -   a computer;    -   a scanner;    -   a forming robot, and a medical guide template, and a medical        device;        wherein:    -   the markers represent physical reference points on a bodily        part;    -   the scanner is capable of scanning the bodily part with the        markers thereon;    -   the computer is operationally coupled to the scanner and forming        robot, and configured to allow to allow the computer to:        -   receive an image from the scanner.        -   establish a relation between the markers and a target or            trajectory identified on the image, and        -   establish forming data transferred to the forming robot;    -   the robot is capable of deforming the template into an        operational medical guide adapted to allow the medical device to        be aligned with the target or trajectory.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings. With specific reference now tothe drawings in detail, it is stressed that the particulars shown are byway of example and for purposes of illustrative discussion of thepreferred embodiments of the present invention only, and are presentedin the cause of providing what is believed to be the most useful andreadily understood description of the principles and conceptual aspectsof the invention, in this regard, no attempt is made to show structuraldetails of the invention in more detail than is necessary for afundamental understanding of the invention, the description taken withthe drawings making apparent to those skilled in the art how the severalforms of the invention may be embodied in practice.

The present invention will be understood and appreciated more fully fromthe following detailed description, taken in conjunction with thedrawings in which:

FIG. 1 schematically illustrates a probe extended from a medical devicealong a trajectory that leads the probe to a target in a patient using amedical guide in accordance with an exemplary embodiment;

FIG. 2 depicts in a block diagram a method for formation an operationalmedical guide in accordance with an exemplary embodiment;

FIG. 3 schematically illustrates a template in accordance with anexemplary embodiment going through deformation;

FIG. 4 describes a kit comprising a template that is packaged in asterilizable bag in accordance with an exemplary embodiment:

FIG. 5a schematically illustrates an example of a generic templatehaving one leg to couple to rigid body parts of a patient in accordancewith an exemplary embodiment;

FIG. 5b schematically illustrates the template shown in FIG. 5a afterdeformation;

FIG. 5c schematically illustrates a template provided with anenhancement in accordance with yet another exemplary embodiment.

FIG. 6a schematically illustrates a generic template in accordance withan exemplary embodiment, placed in a forming system;

FIG. 6b schematically shows the generic template shown in FIG. 6a afterbeing deformed;

FIG. 7 illustrates an example of another deformable template inaccordance with an exemplary embodiment;

FIG. 8 depicts another template in accordance with an exemplaryembodiment;

FIG. 9 shows the template shown in FIG. 8, placed within a guide-formingmachine in accordance with an exemplary embodiment;

FIG. 10 depicts an embodiment built from bags hat contain for examplemixtures of glue and other materials or just glue or other materialsthat can transform the template into a rigid object in accordance withan exemplary embodiment.

FIG. 11 schematically depicts an operational guide that is formed toconform with the complex contours of the gum or a tooth/teeth of thepatient in accordance with an exemplary embodiment.

FIG. 12a schematically illustrates a template before deformation m 10accordance with an exemplary embodiment.

FIG. 12b schematically illustrates the template shown in FIG. 12a afterdeformation.

FIG. 12c schematically illustrates the deformed embodiment shown in FIG.12b provided with an accessory for a trajectory.

FIG. 13 schematically illustrates another embodiment of a surgical guidein its operational form.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be further described in detail herein below. Itshould be understood, however, that the intention is not to limit thedisclosure to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternatives.

DETAILED DESCRIPTION OF THE INVENTION

According to one aspect, medical guide templates comprising deformablematerials and/or deformable structures are provided, that becomeoperational guides after deformation.

Some guide embodiments and systems for production thereof are provided,that do not comprise deformable materials, but rather comprisecomponents that can be moved to deform into a guide and prevent collapseof the guide during deformation.

Some guide embodiments are provided that are not created by deformation,for example they are created by 3-D printing, as further discussedbelow.

According to another aspect, forming systems and methods for preparingthe operational guides from the guide templates are provided.

According to yet another aspect, sets comprising various deformableguide templates are provided.

Yet another aspect concerns kits comprising receptacles containingtherein sterilizable medical guide templates, and systems and methods toproduce them.

Reference is now made to FIG. 1 schematically illustrating a probeextended from a medical device along a trajectory in accordance with anexemplary embodiment. As schematically shown in FIG. 1, a probe 11 isextended from a medical device 10 along a trajectory (broken line) thatleads the probe 11 to a target 21 in a patient 20. A medical guide 100″helps make the access of the probe 11 stable, planned and accurate. Theproper access entails appropriate trajectory alignment of the guide100″, which in turn requires the guide 100″ to have a suitable geometry.However, since both the patient's features and the targets/trajectorieswidely vary between patients, guides of different geometries arerequired in different operations.

Various solutions have been proposed to adjust the geometry of the guideor to customize the geometry to an operational guide for a particularoperation. However, to the best of our knowledge, none of the solutionsprovide operational guides that are made of materials or structures thatcan be deformed to their final form in the operation room before orduring operation. The operational guides in accordance with theembodiments taught in the present disclosure are made from deformedtemplates that can be rapidly formed.

FIG. 2 depicts in a block diagram a method embodiment for formation ofan operational medical guide of a template 100″, by a guide formingsystem 200. Major components in the forming system 200 are: a computer230, a scanner 240, and a forming robot (or machine) 250. Preferably,computer 230 receives information from 3 sources: the scanner 240 thatscans the bodily part, the template 100″ that was chosen for theparticular procedure, and the type of markers 22 or anchoring element 14that were used that represents physical reference points on that bodilypart. The information is being calculated to establish forming data thatis being transferred to a machine such as a forming robot 250 thatdeforms the template into a guide that can be used in the operation.

It should be emphasized that the method as described herein can beperformed within the operation room or near it and the production of theguide is being made on the site and within a very short while so that itcan be utilize during the operation without the need to perform earlierfabrication in a remote location as being performed in the priortechniques.

It should also be emphasized that the element and process described inFIG. 2 does not have to be performed at the same time and can be done indifferent occasions. For example, engaging the markers on the patients(e.g. through implantation or through a sticker label on patient body)or scanning of the patient can be performed before the forming processis done, also forming of the template guide into an operational guidecan be performed hours, days or even weeks before the operations in.

Optionally, the disclosed method can be performed in a sterileenvironment. This option even promotes the possibility to perform theformation of the guide within the operation room since it makes thesterilization process redundant.

Referring back to FIG. 1 as well, markers 22 or anchoring elements areengaged with the patient's body 20 preferably proximal to the target 21,preferably on hard surfaces that allow the engagement to be steadfast.The scanner 240 is employed to obtain an image that includes indicationsof the markers 22; the target 21 and the trajectory 11 are determinedfrom the image as well. As mentioned herein before, the computer 230 isfed with the image as well as the structure parameters of a templatethat is chosen to accord with a specific operational procedure. Thecomputer 230 calculates forming data from the image and the structureparameters. The forming data is conveyed to the forming robot 250 thatdeforms the template 100′ to an operational guide 100″ so that when theoperational guide 100″ is engaged with the markers 22 or the anchoringelement 14, a medical device 10 is properly aligned with the target 21,E.g. passing through trajectory 11, reaching exactly to target 21. Inother examples multiple parallel trajectories and targets on thosetrajectories can be accessed correctly with the same operational guide.In other examples, trajectory can be a restricted planar area on animaginary plain.

FIG. 3 schematically illustrates deformation of a template embodiment100′. The template 100′ comprises a targeting element 110′, connectivestructural elements 120′, and a base element 130′. The device 10 (seeFIG. 1) the operational guide 100″, and the anchoring element 14 mayeach have an aperture (not shown), through which an electrode or otherdevice such as a guide tube, an optic fiber, a biopsy needle, drill, sawor an ablation device, and/or radiation such as noninvasive gamma rays,can be introduced into a patient's brain, internal organ, or a joint,etc. The targeting element 110′ is intended to be coupled to the medicaldevice 10, the base element 130′ is intended to be coupled to themarkers 22 or the anchoring element 14, and the connective elements 120′connect the targeting element 110′ to the base element 130′.

A certain template from a variety of templates may be used in varioussurgeries, such as hip replacement, knee replacement, ENT, dental,spinal procedures etc. In some optional embodiments, multiple targetscan be targeted with the same template, which comprises multiple baseelements and/or multiple targeting elements. For example, such templatesmay be required in epilepsy surgeries, and in spine surgeries.

Preferably, a forming machine such as a robot includes an upper arm 254that is engaged with the targeting element 110′ and a lower arm 252 thatis engaged with the base element 130′. The template 110′ is eithermalleable or is made so by the employment of a plasticizer, specificallyto FIG. 3, a heater 256, which is controlled by the computer 230.Optionally, the robot can be provided with a controller that controlsthe heater 256.

Since the template 100′ is made of materials or made from parts havingmultiple degrees of structural freedom, the robot then repositions thetargeting element 110′ with respect to the base element 130′ of thetemplate 100′, to form an operational guide (not shown) of anappropriate alignment.

Typically, the connecting elements 120′ are malleable components. Othermeans that produce an effect of making the template malleable may beused: for example, lighting with a corresponding wavelength; passingelectric current with an electric device through a suitable material.Other exemplary embodiments may comprise glue that is uncured beforedeforming the template and quickly cures after the deformation, as willbe further discussed below.

Some embodiments of such templates are mechanically deformable templateswhere UV glue is applied in strict areas (typically various joints), andthe glue is cured after a required shape is assumed, thereby providing arigid required form. Such glue may be applied at the factory where thetemplate is manufactured, and cured long thereafter, close to the timeof use. Suitable glues may allow the curing to be performed even yearsafter being applied.

Some template embodiments comprise deformable components that arecurable. In some system embodiments the curing can be done by the robotthat does the deformation; in other system embodiments another componentof the system performs the curing. In preferred embodiments the completeprocess of preparing the operational guide takes about 10 s. Thereforean operation can essentially continue uninterrupted even when during theoperation physicians discover that a new customized guide is required.The curing method and apparatus are selected according to the malleablematerial that is selected. The curing can be for example cooling; UVradiation; exposing the template to oxygen, etc.

According to another aspect, a set of deformable templates are provided,each template having a different structure such as length and/or angleof the structural elements relative to the base element. For eachmedical procedure, a template can be selected from the set that requiresminimum time to prepare. Typically, the structure of this selectedtemplate is closest in alignment to the required structure.

Some kits may comprise deformable templates having other characteristicssuch as strength of material that vary between the templates. Thetemplate for use may be selected in such kits according toconsiderations other than the minimum time required to prepare, oraccording to multiple considerations that may be selectable by theoperating physician.

In some embodiments, the preparation includes sterilization of thetemplate and/or the operational guide prepared therefrom or maintainingthe sterility of the template since usually the desired guide should bedelivered to its use in a sterile manner to be used in a surgicalprocedure.

Reference is now made to FIG. 4 that describes a kit 1000 comprising atemplate 300′ in sterile condition is packaged in a sterilizable bag 40′that can provide a sterile barrier against contamination of the template300′ and allows preparing the operational guide even in the operatingroom. The bag 40′ is configured to allow the forming system to form anoperational guide while maintaining the sterility of the template 300′.

However, some kit embodiments (not shown) comprise a bag that is notsterilizable, but rather is configured to otherwise allow the guide tobe protected, for example from dirt, scratches, blows, tampering etc.

A first element 41′ extends from the bag 40′ and is attached to one sideof the bag 40′, for example glued onto the sterile bag 40′. In otherembodiments the first element can alternatively be attached through acoupling between an external cap and an internal base or targetingelements with the bag between them. A second element 44′ is attached toanother side of the bag 40′.

Some embodiments comprise a sterilizable bag and a template therein, andfurther comprise at least one modifier element on or in the bag that canbe engaged with the forming system. These modifier elements may be thetargeting elements and/or the base element of the template or may beanother component that is not part of the template and merely serves tocouple the template with the forming system. The modifier elements areeach configured to allow one or more of the following:

Mechanical engagement of the template, for example with the formingsystem, that allows immobilization of parts of the template that areprogrammed to remain so during the deformation of the template, anddeformation of parts of the template that are programmed to deformduring the deformation.

Transfer of force and/or energy from the forming system to the template.Such transfer may include conversion of the force/energy from one forminto another; for example, the connective structural elements maycomprise or have therein or thereon coils that are electricallyinductable to heat the structural elements and deform them to theirprogrammed form in the operational guide.

In yet other embodiments, the deformation docs not require a modifierelement for transfer of force and/or energy. For example, the formingsystem may comprise UV-radiating means that can be focused onUV-deformable components of the template. In some embodiments there isno need for modifier elements for mechanical engagement as well. Thelatter embodiments deform into the aligned form by the remoteapplication of energy by the forming system to the template.

In some embodiments, the bags are made of a material that can generateheat under the influence of UV light radiation or radiation at anotherwavelength.

Some deformations require application of considerable energy to thetemplate. The applied energy might cause application of a great amountof heat on the template that might adversely affect the template fromprolonged exposure to heat. Therefore, some bag or template embodimentsfurther comprise heat-removing means that facilitate removal of heatfrom the template. Such means may be selected from: radiation-deflectorssuch as mirrors; mechanical devices such as fans inside the bag thatblow air inside the bag to outside the bag via a one way-valve and/orfans that blow air over the bag; compositions inside the bag that canreact in a endothermic reaction that can be induced to occur during orafter the deformation, and combinations thereof. The template mayfurther comprise articles of low heat-conductivity that can help isolatethe parts that are not intended to be deformed from heat. Multifocusingof the radiation, i.e. using multiple light sourcing on one area, mayhelp to quickly heat a very specific area with minimal heating outsidethe selected area.

Depending on the treatment methods and curing methods used to reform thetemplate into its soft state and set the template in its final alignedform, respectively, the sterile hag can include an indicator thereon ortherein to indicate the reliability of the treatment, e.g. a UVindicator that can indicate if the template absorbed an excessively highlevel of UV light before being brought to the forming system; meaningthat if the target curing method relies on UV radiation then thetemplate was corrupted. Oxygen may be introduced into the bag via aseptum or one-way valve to cure and an oxygen indicator can be used tofollow the curing. Other indicators like temperature can also beincluded to indicate if there were high temperature events thatinvalidated the target forming abilities.

Some kit embodiments comprise similar bags or other suitable receptaclessuch as jars, and suitable devices other than medical guides, that cansimilarly be placed within the receptacle and formed therein.

Some guide embodiments do not serve for targeting but rather for otherpurposes for example attached to a patient's rigid body part such as abone. Some embodiments are formed that allow aligning a surgical tool ora medical device attached thereto to a certain trajectory pointing to abody target that has a known geometrical relation with the bone.

Some operational guides are customized to juxtapose bones or optionallyspace them apart as is required. The process comprises for example:imaging the bones in order to record their shapes, dimensions and otherphysical features; subsequently computing alignment and spacing of thesebones in relation to each other; selecting a template guide, determiningdeformation data of said template guide; deforming the templateaccording to the data into a final formed operational guide that whenattached on either ends to bones aligns the bones, and optionallydetermining a fixed space between them exactly as determined by theinitial plan. In some operations before the imaging is performed, thesides of the bones that are to be attached to the template are cut andprocessed to suit and couple to the attachment mechanism of thetemplate,

Some guide embodiments comprise places for more than two bones; or evenfor only one bone; some embodiments further comprise joints and/ormoving parts; however, an important aspect is that the guides can becreated from a template by executing deformation based on data deformingthe object into its final orientation and shape.

A customized operational guide′ may sit on screws that are attached topatient bones; these screws can also be used as markers in order togeometrically relate the target and the base of the customized guideallowing the determination of the shape of the customized guide.

The guide may sit directly on bur hole that is drilled in the patient'sbones or may be attached to the skull or sit on another object that issitting on patient skull or other rigid body parts and attaches to thebur hole or the other object at only one point, or to multiple points ina certain predetermined plain. The form of this guide is determinedafter imaging is made; deforming information is determined that isneeded to deform the object so that the targeting and the alignment areoperable through the guide; the deforming information is sent to theforming machine that will deform the generic template into the finalcustom guide; this guide will then be attached to the hole in the boneor to another object attached to the bone in order to direct a surgicalinstrument through a planned trajectory to the certain target.

The surgical tool does not have to be a tool that penetrates the patientbody; instead it could be a tool that needs only to correctly be alignedto patient anatomy; this will be needed if for example if an energy orother non invasive waves are needed to be transferred to a certaintarget.

Reference is now made to FIGS. 5a-5b that schematically illustrateanother example of a generic targeting and alignment template 900″, FIG.5a , that is formed into an operational guide 900, FIG. 5b . The desiredtrajectory of the medical apparatus into the patient body could passthrough the operational guide or even any other axis determined by theshape of the guide. The generic template has one leg to couple withrigid body parts of the patient (or to attach to other object assembly);a medical apparatus can sit on the upper side targeting element 910″while attachment to rigid body parts could be made to the base element930″.

FIG. 5c illustrates an optional template 950 with a resilient frame suchas a springs 960 that prevents the resulting guide from collapse duringthe deformation process. Other such exemplary embodiments will beexplained herein after.

As shown in FIG. 6a , the template 900″ is inserted into the formingmachine 80; here we only show an example of important components of anexemplary machine 80 that comprise an upper attachment plate 83 with aspecial mating place to the targeting element 910″ of the template 900″and a lower plate 84 at the base of the machine 80 which attaches to thebase element 930″ of the template 900″. Subsequently the machine 80 mayinitiate a phase turning the template 900″ into a malleable object 901,shown in FIG. 6b , for example by heat or humidity or other means asindicated herein above, or the template 900″ may be innately malleablebefore any deformation actions, in which case this step may be omitted.Deforming data and instructions are sent to the machine 80. Subsequentlyeither the upper plate 83 or the lower plate 84 or both of them togetherwill move according to deformation instructions until they align theupper plate 83 and lower plate 84 in relation to each other according tothe desired final form of the template.

Arms 86 connect the upper and lower plates through the template so as toset the distances between these plates; and thus determine the plates'orientations and place in space. The arm length may be adjustable e.g.by telescopic arms with a length determined by PC/controller; or by aleading screw that is rotated setting the length of the arms.

After the upper plate 83 and the lower plate 84 reach their finalpositions and orientations as shown in FIG. 6b , according to deforminginstructions, a curing cycle will be made by the forming machine 80 orby another apparatus in the forming system that will turn the objectinto a rigid targeting component assuming the final required shape.

Other types of robots can be employed in order to assist the processwithout limiting the scope of the present invention. Another robot willbe described herein after, however, other possibilities are possible.

Reference now is made to FIG. 7 which schematically illustrates anotherguide that has three attachment legs 620′; each leg 620′ ends with alead end 625′ which in this case each leg should be deformed to exactlyalign with the anchoring points, screws or element. In general thenumber of the attachment legs is at least one leg. The targeting element610′ of the template 600′ should be coupled to a medical and surgicalapparatus, whereas the legs 620′ may be coupled to a patient's rigidbody parts e.g. bones.

Usually the generic template 600′ cannot be used as is for targeting oralignment of a surgical tool to the exact trajectory or target; insteadthe template first needs deformation.

Reference is now made to FIG. 8 depicting another template in accordancewith an exemplary embodiment. Template 700 is made of several parts thatare engaged with each other with multiple degrees of freedom, whereinbetween joints of the parts, glue is provided and confined. Glue ismerely an example, other methods of fixation between parts can beemployed. The glue is uncured so the degrees of freedom are maintained.Similarly to previous shown embodiments, a base 710 and a top 720 platesare provided so as to be attached to a forming machine or when templateis presented inside a bag base 710 and top 720 plates are provided so asto couple to a medical device (not shown) and to be attached to externalcaps (not shown) that in turn attach to a forming machine where the bagis in between. Joints 730 are provided on the base and top plates sothat connecting rods 740 can be jointed to the base and top plates. Theconnecting rods 740 are preferably telescopic arms that can be fixedinto a certain length. As can be understood, the template is fullyflexible, regarding orientation and length.

The template as shown in FIG. 8 is inserted in a machine 50, as shown inFIG. 9. The machine 50 comprises the illustrated components: upperattachment fixation 53, and robotic arms 54 that hold the base component630′ of the template 700.

Once the template 700 is inserted in the deforming machine 50 betweenupper fixation 53 and base component 630, the machine 50, using themovable arms 54 will place the template 700 in the desired andcalculated positioning and orientation. After the template gains itsfinal positioning, a phase or a cycle turning the template 700 into arigid guide is initiated.

Optionally and additionally, instead of starting with a soft templatehaving multiple degrees of freedom, the template can be formed from arigid material that can be softened, for example by heat or humidity orother means and only then, deformed into the desired orientation. Inother embodiments (not shown), one robotic arm sequentially passes overevery telescopic leg (connective element), moves it and locks it (fromany further movement).

As indicated, the machine 50 preferably allows independent movement ofeach arm 54. Such movement can be obtained by coupling for example 6motors to each robotic arm 54. After each robotic arm 54 reaches thefinal position and orientation, then a curing cycle will be made by theforming machine 50 that will turn the template 700 into a rigid guideassuming the final required shape. This cycle can comprise a coolingcycle and/or a heating cycle or a UV curing cycle—the deforming stepsdepend on the physical and chemical structure of the template 700 andthe mechanisms that are effective in making the template 700 soft orrigid.

In another example, template 700 is inserted in the deforming machine 50between upper fixation 53 and multiple robotic arms (not shown). Theserobotic arms should be able to make all movements required to reach to afinal form according to data sent by the PC. For example, each roboticarm should be able to determine the vector orientation of the leg endingattached thereto, and then move the centre of the leg ending to thecorrect place.

It should be noted that when a kit as indicated herein before, where thetemplate is placed within a bag in sterile conditions, the robot isplanned to work over the template while the bag is staying intact duringaction and after. The fact that a bag is being used should not harm theprocess.

In some of the guide-forming embodiments, jigs maybe used to accuratelyplace the templates inside the bags coupling them to external capsduring the production process; after a template is appropriatelypositioned in the bag the jig can be used to firmly engage the templatefrom outside the bag, with upper and lower caps or similar engagementmeans that preferably have contours that closely match contours on thetemplate, typically on components of the template most proximal to thewalls of the bag. Some templates are deformed without being placed in areceptacle such as a bag. These templates nevertheless may requirehandling with suitable engagement means as described above for insertionand/or removal into and/or from the forming machine, in particular whenthe template, before and/or during deformation, is very malleable andmight be overly or wrongly deformed as a result of handling.

Reference is now made to FIG. 10 schematically illustrating examples ofinternal structures of the templates; FIG. 10 depicts an embodiment900′″ built from bags 905′″ that contain for example mixtures of glueand other materials or just glue or other materials that can transformthe template 900′″ into a rigid object by heating or by cooling or by UVlight, by materials that harden when mixed together, or other meansdescribed above. In this example components of the template 900′″ thatare designed to attach to the forming machine (not shown in FIG. 10) aredesigned to be rigid while the bag 900′″ can be made from flexiblematerials. The deforming may involve applying stress to the template900′″ (its legs and other elements of its body) to obtain theappropriate form. This stress can be in the form of stretching a certainelement in the structure, trying to press on it to reduce its size ortrying to bend it or even twist it.

The template may be built from a perforated structure that can withstandthe mechanical stresses put on the structure during the deformingprocess. The internal structure should be designed in a way so that thestructure or portions from it do not break, fracture, collapse, crush orassume any final form that docs not have enough strength to withstandthe final mechanical forces and stresses that will be encountered duringthe application and use of the operational guide. The guide can be alsocreated from materials that will become soft when exposed to heat thenforming can begin; at the end of the forming a curing cycle (for examplecooling) will be initiated in order to make the object rigid in a finaldesired form.

Filling materials (e.g. glass fibers, small plastic parts) can be usedto fill the template deformable body for example for the purpose ofestablishing a structure lowering the amount of expensive curablematerials and for other purposes such as enforcing the final shape ofthe structure or lowering the amount of time needed to cure thetemplate.

Some preferred template embodiments are made from materials that areflexile and soft during the forming phase and rigid after a curingphase, remaining in the rigid phase all through the use and applicationof the object. For example the materials comprise polycarbonate thatbecomes soft in high temperature and then rigid again at a lowertemperature; another example could be a template that is internallybuilt from rings, wherein it is easy to adjust the legs' of the templateand even include UV-curable glue; when the template is formed in desiredform then UV radiation will be applied on the deformed template, forcingthe glue to cure and turning the deformed template into a rigid form, anoperational guide.

Some embodiments comprise a mechanism in the template wherein onceeverything in place locking screws are screwed by the forming system,forcing the template to lock in a certain desired form. The locking canbe by press locking, i.e. locking a moving mechanism by pushing a pin.

To prevent undesirable collapse of connecting structural elements as aresult of the deformation of the templates, some template embodimentscomprise supporting means for the structural elements, as shown in FIG.5 c.

Structural elements may comprise various resilient means that helpprevent collapse the structural element during deforming of thetemplates such as a malleable and curable rod inside a spring; astructural element comprising a spring inside a deformable and curablesleeve; a spring inside a deformable and curable rod; or a first springpositioned within a second spring, or even a structural element inaccordion-form.

The structural elements may comprise rigid elements that allow thedesired deformation without the collapse: a telescopic structuralelement comprising two cylindrical rods for example. The element maycomprise a resilient locking pin which may be brought to a groove orhole to lock the element. Each structural element may comprises beadswith a wire or string passing therethough that is controllable by theforming system. The wire/string is held fast at the distal end of thestructural element, for example a knot is tied on the last bead, andpulling the wire/string causes the structural element to bend. In someembodiments the string/wire can be pulled in various directions in orderto allow various deformations of the template.

An advantage of templates without curable elements is that they aretypically easily reverted to their original form, or can be easilyconverted to yet another form, i.e. they are generally more amenable tomultiple uses. Moreover, there is less of a problem of removing excessheat after the deformation. However, the curable templates may moreeasily conform to complex geometries that are desired.

A structural element may comprise an internally slotted head that allowstwo rods to slide therein. A lock can be employed to affix the rods tothe head when the template assumes the desired form.

One particular application of the deformation of templates intooperational guides is for dental procedures such as installation ofdentures. FIG. 11 schematically depicts an operational guide 1500″ thatis formed to conform with the complex contours of the gum or atooth/teeth of the patient. A targeting element 1510″ may serve both todirect a treatment device (not shown) to the target 10″ and as a handleto assist in correct placement of the guide 1500″ on the gums or amarker placed thereon. Due to the small size of the templates, someembodiments may be deformed and cured in-situ. However, as opposed tothe methods described above, usually first the malleable base componentof the template is conformed in shape to the surface of an oral regionadjacent to the target, and only then an image is taken with thetemplate in place, the template is removed from the oral cavity anddeformed (without altering the shape of the base component) andreintroduced into the oral cavity to the appropriate location therein.

In another embodiment, the base remains in the oral cavity and aminiature template is deformed and then attached to the base duringoperation. As an example, two curable materials can be used for thecombined template and base, each is cured in a different method. Duringcuring of the base, a first curing method is used and during curing ofthe template another curing method is used. Alternatively, one curingmaterial is used, but care should be given as to shield the curingmaterial in the template portion during the curing of the base.

According to another aspect, it is important to note that in dentalguides and sometimes in other guides for other indications (e.g. spine),multiple guiding elements can be embedded in the template and alignedcorrectly within the same template by multiple robotic deformationssteps. In the purpose of directing surgical tools in differenttrajectories according to plan when the guide becomes operational. Insuch cases where deformation is done serially by the forming machinecertain shielding should exist to limit the spread of the curingmechanism into neighboring guiding elements that are still unalignedduring the deforming process.

Reference is now made to FIGS. 12a-12c illustrating a template beforedeforming, after deforming and with an accessory for finding thetrajectory, respectively. FIG. 12a shows an example of a template thatis totally built from one bulk of plastic material that softens andcures into a final rigid shape according to methods described earlier.It is shown that the template in its generic form, have a base of thetemplate which will at end attach to the anchoring points or anchoringstructure of the medical device, and at the same time will be directlyor indirectly be attached to a robot base or arm; 1120 is the portion ofthe template that connects to the medical device or to an arm thatconnects to the medical device; 1130 is the plastic bulk to be deformed.After template 1100 is inserted in the robot, the robot will deform itas required according to methods described herein before. This is shownin FIG. 12b showing how the bulk of the plastic material is now of adifferent shape 1100′ aligning portion 1120 relative to base 1110; afterwhich a medical device 1140 which is shown in FIG. 12c is attached to.Alternatively, 1140 could be a handle that the medical device attachesto at attachment location 1150. it is important to note that in thisexample trajectory of medical device into the body does not pass throughtemplate base 1110.

It is another aspect of the invention in which base 1110 can also bepart of the plastic bulk, it will be shaped to its required shape bypressing the plastic bulk against a pattern held by the robot base. Thiswill form a pattern in the base of the template which mates correctlywith the anchoring points or anchoring element so that when curedoperational guide 1100′ will become rigid and be ready for use.

Reference is now made to FIG. 13 illustrating another embodiment of asurgical guide in its operational form where trajectory 905 of themedical device passes to the body and does not pass through the base ofthe template. In such cases, the medical device will sit and attach to amating place on arm 900 in place 904. In such cases, forces activated onthe medical device or on the arm will lead to structural force momentsthat might lead to bending of the arm, tearing of the arm from thestructure tearing of the base from the attachment structure orattachment points. For this connecting elements 906 are also suppliedconnecting the arms with the base distributing the forces to theoperational guide base, In other examples, these connecting elementsbetween the upper arms and the base could be another mechanicallyadjusting arm instead of plastic material that cure. 901 is where thearm attaches to the upper side of the template, the upper side 902 oftemplate where forces may tear the upper side of the template or the armfrom the template body during the operational template use. 903 showsreinforced base of template on counter side of the arm with someengagement mechanism strengthening the hold of the template to theanchoring structure. 904 shows medical device attachment and matingportion of the handle, 905 show the trajectory of the medical device notpassing through the base of the template, 906 shows connecting structurethat supports the arm by distributing the forces encountered by the armto the template base.

It is to be understood that the above description is intended to beillustrative, and not restrictive. For example, the above-describedembodiments (and/or aspects thereof) may be used in combination witheach other. In addition, many modifications may be made to adapt aparticular situation or material to the teachings of the variousembodiments of the invention without departing from their scope. Whilethe dimensions and types of materials described herein are intended todefine the parameters of the various embodiments of the invention, theembodiments are by no means limiting and are exemplary embodiments. Manyother embodiments will be apparent to those of skill in the art uponreviewing the above description.

This written description uses examples to disclose the variousembodiments of the invention, and also to enable any person skilled inthe art to practice the various embodiments of the invention, includingmaking and using any devices or systems and performing any incorporatedmethods. The patentable scope of the various embodiments of theinvention is defined by the claims, and may include other examples thatoccur to those skilled in the art. Such other examples are intended tobe within the scope of the claims if the examples have structuralelements that do not differ from the literal language of the claims, orif the examples include equivalent structural elements withinsubstantial differences from the literal languages of the claims.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims. In addition, citation or identification of anyreference in this application shall not be construed as an admissionthat such reference is available as prior art to the present invention.

The scope of the present invention is defined by the appended claims andincludes both combinations and sub combinations of the various featuresdescribed hereinabove as well as variations and modifications thereof,which would occur to persons skilled in the art upon reading theforegoing description.

1. A process for generation of an operational medical guide, the processcomprising: providing a medical guide template making the medical guidetemplate malleable, deforming the malleable medical guide template intoan operational medical guide having a desired and structuralconfiguration, wherein the deforming comprises applying stress on atleast a part of the medical guide template; and rigidifying thestructural conformation of the operational medical guide therebyobtaining an operational medical guide with a desired fixed structuralconfiguration.
 2. The process of claim 1, wherein the rigidifyingcomprises curing and wherein the curing comprises cooling; heating,exposing the template to oxygen, electric current, electric induction orany combination thereof.
 3. The process of claim 1, wherein said medicalguide template comprises or made of a curable material.
 4. The processof claim 1, wherein making the medical guide template malleablecomprises applying one or more of irradiation, heating, cooling,electric current, electric induction, or any combination thereof on themedical guide template.
 5. The process of claim 1, wherein theoperational medical guide is configured to facilitate or assist indelivery of at least one medical device to a target area along one ormore trajectories defined by the fixed structural configuration of theoperational medical guide.
 6. The process of claim 1, wherein theapplying stress comprises stretching, applying pressure, bending,twisting or any combination thereof.
 7. A process for generation of anoperational medical guide, the process comprising: providing a medicalguide template having a malleable structural configuration, deformingthe medical guide template into an operational medical guide having adesired and structural configuration, wherein the deforming comprisesapplying stress on at least a part of the medical guide template; andrigidifying the structural conformation of the medical guide therebyobtaining an operational medical guide with a desired fixed structuralconfiguration; wherein the entire process is performed while the medicalguide template is enclosed within a receptacle configured to maintainsterility of the medical guide template.
 8. The process of claim 7,wherein the rigidifying comprises curing, and wherein the curingcomprises cooling, heating, exposing the template to oxygen, cooling,electric current, electric induction or any combination thereof.
 9. Theprocess of claim 7, wherein the rigidifying comprises locking, whereinthe locking comprises press locking and/or pushing a pin.
 10. Theprocess of claim 7, wherein said medical guide template comprises or ismade of a curable material.
 11. The process of claim 7, wherein themedical guide template is inherently malleable.
 12. The process of claim7, further comprising making the medical guide template malleable priorto the deformation.
 13. The process of claim 12, wherein making themedical guide template malleable comprises applying one or more ofirradiation, heating, cooling, electric current, electric induction, orany combination thereof on the medical guide template.
 14. A medicalprocedure comprising: obtaining a medical guide template having amalleable structural configuration, obtaining an image of an anatomicalstructure and imposing a coordinate system thereon, wherein thecoordinate system identifies a desired trajectory of a medical device;determining a desired structural configuration of the medical guidetemplate based on the identified trajectory; deforming the medical guidetemplate into an operational medical guide having the desired structuralconfiguration, wherein the deforming comprises applying stress on atleast a part of the medical guide template; and curing the operationalmedical guide, thereby rigidifying the structural conformation of themedical guide so as to obtain an operational medical guide with thedesired structural configuration being fixed; directing a medical devicealong the trajectory using the operational medical guide, therebyassisting in the performing of the medical procedure.
 15. The method ofclaim 14, wherein the curing comprises cooling, heating, exposing thetemplate to oxygen, electric current, electric induction or anycombination thereof.
 16. The method of claim 14, further comprisingmaking the medical guide template malleable prior to the deformation.17. The method of claim 16, wherein making the medical guide templatemalleable comprises applying one or more of irradiation, heating,cooling, electric current, electric induction, or any combinationthereof on the medical guide template.
 18. The method of claim 14,wherein the medical procedure is a surgical procedure.
 19. The method ofclaim 14, wherein the medical procedure is selected from hipreplacement, knee replacement, an ENT procedure, a dental procedure, aspinal procedure.
 20. The method of claim 14, wherein the medicalprocedure is a brain surgery.